NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER 1-1/4" CTF
Received Feb 19, 2019 · Event occurred Feb 13, 2019
Report 1119193-2019-00007 · MDR key 8350486
Device
Generic name
New Image Flextend Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
14602
Lot number
UNKNOWN
Product problems
- Patient-Device Incompatibility
Patient
3 YR
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW NOT POSSIBLE BECAUSE LOT NUMBER NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. WEIGHT OF END USER NOT KNOWN SO ESTIMATION WAS USED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED BLISTERS AND A RASH WHICH STARTED UNDER THE TAPE PORTION OF THE OSTOMY BARRIER BUT EXTENDED TO HER PUBIC AREA. THE BLISTERS WERE PUS-FILLED. END USER WAS PRESCRIBED AMOXICILLIN.